Central Monitor School

hace 4 semanas

Ciudad de México Novasyte A tiempo completo

Job Overview

Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts. To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.

Develop and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study. Support project management team to develop monitoring strategy including monitoring triggers/thresholds. Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)

Essential Functions
- Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.;
- Perform remote monitoring visits for assigned sites as assigned.;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;
- Perform Study specific analytics based on applicable study specific plans. Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value.;
- Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
- Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;
- Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
- Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
- Ensure complete and accurate documentation of all the site-specific tools and templates and keep the sites audit ready.;
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the Site-specific information.;
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
- Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.;
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;
- Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;
- Work in accordance of the Study Central Monitoring Plan.;
- Establish and maintain effective project/ site level communications with relevant stakeholders.;
- Provide Mentorship to Associate Central Monitors.;
- Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
- Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
- Analyze the complexity of the requirements and provide the EAC hours and turn around time.;
- Review of the Study Central Monitoring Plan
- Attend Kick-Off meetings, weekly team meetings, a

  • Heritage Elementary School Long-Term District Pool Substitute_ESCCO/HES

    hace 2 días

    Ciudad de México Olentangy Local School District A tiempo completo

    Heritage Elementary School has a Long-Term District Pool Substitute  position available within Olentangy Schools for the 2024-2025 school year. District Pool Substitutes will be compensated at a rate of $170 per work day (no benefits) and assigned to a primary building within the district, but could be directed to an alternate building/assignment based...

  • Regional Operations Director

    hace 6 días

    Ciudad de México International School Partnership Careers A tiempo completo

    Regional Operations Director - Mexico and Central America Position at ISP Mexico and Central America Regional Operations Director Purpose of Role ISP is one of the fastest growing and largest school groups in the world, with over 80 schools present in more than 20 countries. We are looking for t alented and experienced operations managers (across a...

  • Elementary Teacher

    hace 4 semanas

    Ciudad de México Northridge School Mexico A tiempo completo

    Contract Length: 1 year Number of Vacancies: 1 Student Level: Early Childhood, Elementary Eligible Candidates: University Graduate, Licensed Teacher Requirements: Education Required: Bachelor Minimum Teaching Experience: 3 years of teaching experience Major: Education, Humanities, Social Sciences, Psychology, Sociology, History Required Certificates:...

  • Elementary Teacher

    hace 4 semanas

    Delegación Cuajimalpa de Morelos, Ciudad de México Northridge School Mexico A tiempo completo

    *Resposnibilities: Plan, prepare, develop, and teach classes at LE. Motivate students with innovative, imaginative, enthusiastic, and dynamic classes. Maintain discipline in class, solving problems that may arise as a result of poor student behavior. Preserve the positive relationship among students, parents, academic, and administrative staff. Upload...

  • Paraprofessional (Part-Time Instructional Support)

    hace 3 semanas

    Ciudad de México Allentown School District A tiempo completo

    Paraprofessional (Part-Time Instructional Support) Starting Salary: $18.34/hr. Qualifications: Must meet educational requirements for “highly qualified paraprofessional,” as defined by the federal laws and No Child Left Behind. Must meet basic reading, writing, and math competencies. Valid Act 34, 114, and Act 151 clearances. Valid tuberculosis test and...

  • Sciences Lab Teacher for Elementary School Fully

    hace 4 semanas

    México Escuela John F. Kennedy A.C. A tiempo completo

    JOB OPENING! With an over 50-year tradition educating the future leaders of Mexico, John F. Kennedy - The American School of Querétaro is an innovative bilingual K-12 school in central México accredited by the International Baccalaureate Organization (IB), AdvancED (United States), and the Secretaría de Educación Pública (SEP) that serves over 1,400...

  • Spanish Teacher for High School

    hace 4 semanas

    México Escuela John F. Kennedy A.C. A tiempo completo

    JOB OPENING! With an over 50-year tradition educating the future leaders of Mexico, John F. Kennedy - The American School of Querétaro is an innovative bilingual K-12 school in central México accredited by the International Baccalaureate Organization (IB), AdvancED (United States), and the Secretaría de Educación Pública (SEP) that serves over 1,400...

  • Supervisora / Monitora de Transporte Escolar

    hace 1 semana

    Ciudad de México The American School Foundation A tiempo completo

    Auxilia y supervisa el bienestar y la disciplina de los alumnos en el camión. **EDUCACIÓN Y REQUISITOS DE CERTIFICACIÓN** - Estudios de secundaria terminados **CUALIDADES Y EXPERIENCIA PREVIA REQUERIDAS** - Facilidad para trabajar en cooperación y comunicación con muchas personas **DEBERES Y RESPONSABILIDADES** - Mantiene el orden y disciplina en el...

  • 3rd Grade Teacher

    hace 2 días

    Ciudad de México Horry County Schools A tiempo completo

    Job Summary Position requires the planning, organization, and implementation of the appropriate instructional program to address the learning needs of the students; to guide and encourage students to develop and fulfill their potential in both curricular and extracurricular activities. Essential Duties Plan, prepare and deliver instructional...

  • Special Education Teacher

    hace 4 semanas

    Ciudad de México Horry County Schools A tiempo completo

    Job Summary Position requires the planning, organization, and implementation of the appropriate instructional program to address the learning needs of the students; to guide and encourage students to develop and fulfill their potential in both curricular and extracurricular activities. Essential Duties Plan, prepare and deliver instructional...

  • Central America Investment Manager

    hace 4 semanas

    México Global Impact Investing Network A tiempo completo

    Alterfin is looking for an Investment Manager to supervise a portfolio of partners in Central America. The position will be based in one of our key countries of operations in the region (Guatemala, Honduras, Nicaragua, Mexico), with frequent travels within the region and an annual trip to Brussels. This position involves responsibility for the development...

  • Program Manager, Central America and Mexico

    hace 2 semanas

    Ciudad de México Internews Network A tiempo completo

    ABOUT THE OPPORTUNITY Under the supervision of the Regional Director for the Americas, the Program Manager performs high level tasks and has overall responsibility for a portfolio of various projects in multiple countries, including financial oversight. The Program Manager establishes technical and operational plans for all initiatives across the Central...

  • Routing Coordinator.

    hace 4 semanas

    Ciudad de México Amazon A tiempo completo

    Routing Coordinator. (Night shift), AMZL Central Operations Amazon Mexico is seeking a highly skilled and motivated person to develop robust transportation network capabilities in Mexico. The role requires working with internal and external stake-holders to design, plan, implement and execute inbound and outbound transportation network required to...

  • Graphic Artwork Coordinator

    hace 4 semanas

    Ciudad de México Zoetis A tiempo completo

    The Graphic Artwork Coordinator will ensure delivery of the artwork needed for relabeling purposes. The Graphic Artwork Coordinator will define metrics to close Quality Notifications (QNs) on the established time, identifying periodic goals for the accomplishment of the annual objectives, according to the needs of the involved markets. The Graphic Artwork...

  • Edtech Coordinator

    hace 1 semana

    México Escuela John F. Kennedy A.C. A tiempo completo

    With an over 50-year tradition educating the future leaders of Mexico, John F. Kennedy - The American School of Querétaro is an innovative bilingual K-12 school in central México accredited by the International Baccalaureate Organization (IB), AdvancED (United States), and the Secretaría de Educación Pública (SEP) that serves over 1,400 students from...

  • Routing Coordinator.

    hace 5 días

    Ciudad de México Amazon A tiempo completo

    Routing Coordinator. (Night shift), AMZL Central Operations Amazon Mexico is seeking a highly skilled and motivated person to develop robust transportation network capabilities in Mexico. The role requires working with internal and external stake-holders to design, plan, implement and execute inbound and outbound transportation network required to...

  • Kering Latam Logistics Coordinator

    hace 2 semanas

    Ciudad de México, Ciudad de México KERING A tiempo completo

    KERING LATAM Logistics CoordinatorJob Family: Supply Chain - Warehousing & Logistics - DistributionJob Title: LATAM Logistics CoordinatorLocation: Mexico City, MXA global Luxury group, Kering manages the development of a series of renowned Houses in Fashion, Leather Goods and Jewelry: Gucci, Saint Laurent, Bottega Veneta, Balenciaga, Alexander McQueen,...

  • English Teacher

    hace 1 semana

    Ciudad de México Kids&Us A tiempo completo

    At Kids&Us, we are the trigger that ignites the new generations to discover the world through their senses. We are passionate about changing the education landscape by building a world full of meaningful English educational experiences. We are proud to have a wonderful and diverse community of teachers all over the world. For our school in Coyoacan we are...

  • LATAM Logistics Coordinator

    hace 2 semanas

    Ciudad de México Kering A tiempo completo

    SummaryThe Logistics Coordinator is responsible for daily follow up on import and export operations throughout the Region (Mexico, Brazil, Chile, Panama, Aruba, Dominican Republic, and emerging markets), partnering with local brokers, freight forwarder and courier companies; coordinating and ensuring merchandise is delivered as planned. The coordinator will...

  • LATAM Logistics Coordinator

    hace 2 semanas

    Ciudad de México, Ciudad de México Kering A tiempo completo

    SummaryThe Logistics Coordinator is responsible for daily follow up on import and export operations throughout the Region (Mexico, Brazil, Chile, Panama, Aruba, Dominican Republic, and emerging markets), partnering with local brokers, freight forwarder and courier companies; coordinating and ensuring merchandise is delivered as planned. The coordinator will...